The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID, Division of AIDS, as the Investigational New Drug (IND) Application sponsor for a large number of DAIDS-funded clinical trials, has a requirement to monitor clinical trials to ensure compliance with DAIDS, domestic and country-specific regulatory requirements and guidelines, verify the accuracy and completeness of clinical trial data, and assess adherence to protocol-specific requirements. The NIAID, Division of AIDS, is seeking a contractor to provide comprehensive clinical site and study monitoring services for the NIAID/DAIDS extramural clinical trial research portfolio. The scope of activities to be performed includes:

The Contactor shall provide (1) quality assurance auditing of the performance of clinical site monitoring functions for NIAID/DAIDS-supported domestic and international clinical research sites and protocols and, (2) independent for cause auditing of clinical research sites. The scope of activities to be performed by the Contractor shall include:

development and implementation of Standard Operating Procedures (SOPs) specific to each of the two main auditing functions

development and implementation of audit plans specific to each of the two main auditing functions

conduct of the following audits (See SOW Exhibit 1):

audits of completed routine and specialized clinical site monitoring visits performed by the clinical site monitoring contractor/entities, and audits of completed remedial and for cause clinical site monitoring visits performed by the clinical site monitoring contractor/entities

coordination and collaboration with other clinical research support contractors and clinical research networks and sites

operation and maintenance of a database of contract-generated reports and other information/materials

development and implementation of an internal Quality Assurance/Quality Control (QA/QC) Plan and an Integrated Master Project Plan

It is anticipated that one cost reimbursement level of effort type contract will be awarded for a base period of one year on or about February 4, 2010. In addition to the above functions and services to be provided for the Base Period, up to 82 Options for expanded services under the contract may be exercised at the discretion of the Government. These Options are defined as follows: Options 1-6 are for additional years; Options 7-34 are for increased level of effort and Options 35-82 are for expanded audits of the performance of Clinical Site Monitoring functions.

THE NAICS Code is 541712 with a size standard of 500 employees. All responsible small businesses may submit a proposal which will be considered by the Agency. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.